Renal disorders form important components of both “lifestyle” and “infective” diseases in humans. Both types of diseases can lead to chronic kidney damage and can progress to end stage renal disease and chronic renal failure. Complicated urinary tract infections and nephrotic syndrome represent the most common and important group of disorders that constitute a major cause of chronic renal failure.
An important renal disease associated with morbidity and progress to end stage renal failure is chronic recurrent urinary tract infection, which can lead to rend scarring going to chronic pyelonephritis. Chronic recurrent urinary tract infection is usually treated by therapy with antibacterial agents. However, the development of increasing antibacterial resistance with each episode plays an important role in non-healing with slow and steady progression to a chronic state due to impaired immunity produced by repeated infections.
Urinary tract infections (UTIs) are one of the most common infectious diseases encountered in the practice of medicine today. UTIs encompass a spectrum of clinical and pathological conditions involving various parts of the urinary tract. The syndromes range from symptomatic bacteriuria to peripheric abscess with sepsis. Each has its own unique epidemiology, natural history and diagnostic considerations. Differentiating syndromes associated with UTI have important implications for treatment and prognosis.
Complicated urinary tract infection refers to urinary infection, which occurs in an individual with functional metabolic or structural abnormalities of the genitourinary tract. These abnormalities promote infection through compromising adequate drainage of urine or by establishing a nidus, from which bacteria cannot be eradicated, as in case of diabetics and in renal failure subjects.
Recurrent infection may be either relapse, where infection recurs with the pro therapy infecting organism and suggests a failure to eradicate the organism from the genitourinary tract, or re-infection, where a new organism establishes infection. In recurrent UTI the impaired host defense and the ability of the bacteria to adhere to the cell walls lining the ureters, play an important role in the recurrences.
E. coli is the cause in most of the UTI cases and treatment consists of a course of antibacterials. Other organisms involved are Klebsiella, Proteus, Enterobacter, Citrobacter, Serratia and Pseudomonas. Synthetic antimicrobial agents of the older members of quinolone class such as nalidixic acid have been available for the treatment of UTI. However, these drugs have limited therapeutic utility and the organisms rapidly develop resistance.
Newer drugs such as fluorinated 4-quinolones like ciprofloxacin, ofloxacin, norfloxacin, lomefloxacin, trimethoprim-sulfamethoxazole and other antibacterial agents like amoxicillin, nitrofurantoin and ampicillin are equally efficacious against UTI. Complicated UTIs normally require a longer course of antibacterial therapy that is associated with the various side effects.
Nephrotic syndrome is a condition marked by very high levels of protein in the urine; low levels of protein in the blood; swelling, especially around the eyes, feet, and hands; and high cholesterol. It leads to hypoalbuminemia, lipiduria, hyperlipidemia, with elevated triglycerides and other lipids, and edema.
Nephrotic syndrome can occur with many diseases, including the kidney diseases caused by primary glomerulonephritis, systemic diseases like diabetes mellitus and vasculitis etc., but some causes are unknown. Prevention of nephrotic syndrome relies on controlling these diseases and preventing relapses by use of anti-proteinuric agents including use of steroids and other immunosuppressive agents.
Immunosuppressive agents are often used with frequently relapsing nephrotic syndrome for steroid-sparing effects. Drugs like cyclophosphamide and chlorambucid were initially shown to be effective in prolonging remission but their potential side effects such as carcinogenesis and infertility have limited their use.
Hence there is a need to analyze the present treatment of renal disorders and to develop new effective drug therapies that are devoid of side effects for the above renal diseases.
Tinospora cordifolia also known in India as Guduchi/amruta is one of the Rasayanas which has been designated as “Ekadravya Rasayana” in the ancient Indian system of medicine [Ayurveda] i.e. to be used as a single entity for its pro-host immunostimulant activity and has been called “the Nectar of life”. This is one of the plant products that has been extensively studied as an immunostimulant by well-known practitioners of modern allopathic medicine.
Numerous polyherbal classical and proprietary formulations having Tinospora cordifolia as one of the ingredients, are available in the Indian market as well as for export. Also, products such as ADBAC™ and IMMUMOD™ having Tinospora cordifolia as a single herb component as a natural immunostimulant are commercially available in India. These products claim to contain an aqueous extract of Tinospora cordifolia. 
Extensive experimental and clinical work has shown the immune enhancing effects of Tinospora cordifolia. This has been established to be mediated through stimulation of macrophage activity which in turn leads to increased secretion of granulocyte-monocyte colony stimulating factor (GM-CSF).
PCT patent application WO 9108750 describes the use of parts of the natural plant Tinospora cordifolia for the treatment of cancerous disease.
U.S. Pat. No. 5,529,778 describes a polyherbal composition containing Tinospora cordifolia as one of the constituents for the prophylaxis and treatment of influenza, tuberculosis infection, AIDS, and other immunodeficient conditions. However, the role or advantage of Tinospora cordifolia in the composition is not reported in the patent.
U.S. Pat. No. 6,136,316 describes a polyherbal composition with Tinospora cordifolia as one of the ingredients for treating acute Hepatitis E and Hepatitis B.
U.S. Pat. No. 5,886,029 discloses a composition of epicatechin and gymnemic acid with Tinospora for the treatment of diabetes. Indian patent no. 183805 describes a process for the preparation of immunomodulator from Tinospora and claims polysaccharide as an active principle.
PCT application WO02053166 discloses a formulation comprising a standard herbal extract of Tinospora cordifolia as an immunomodulating agent, a method for the standardization of extract of Tinospora cordifolia, and a method of treatment of a health condition associated with the modulation of immunity such as osteomyelitis, cancer, breast cancer, diabetes, respiratory tract infection, tonsilitis, chronic bronchitis, otitis media, tuberculosis, hepatitis, AIDS, burns, pediatric disease.
Though voluminous data are available on the use of Tinospora cordifolia in various diseases, there is no indication in the published literature regarding the use of Tinospora cordifolia as an immunoadjuvant in the treatment of renal disorders such as chronic recurrent urinary tract infections; both complicated and uncomplicated, and nephrotic syndrome.